MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Vomiting (2144); Hernia (2240)

Event Date 04/29/2022

Event Type  Injury  

Event Description

Title: severe dysphagia is rare after magnetic sphincter augmentation.Authors: milena bologheanu, aleksa matic, joy feka, reza asari, razvan bologheanu, franz m.Riegler, lisa gensthaler, bogdan osmokrovic, sebastian f.Schoppmann.Citation cite: world j surg (2022) 46:2243¿2250.Https://doi.Org/10.1007/s00268-022-06573-2.The aim of this retrospective study is to evaluate the postoperative outcome, especially dysphagia rates, its risk factors and management, in gerd patients undergoing magnetic sphincter augmentation (msa).A total number of 268 patients (male: n=173 and female: n=95, age ranging 38-59 years old) that underwent msa in the period from 2012 to 2020 with a minimum of 2 months follow-up were included in the analysis.Msa was performed as previously described: briefly after the mobilization of the esophagogastric junction, the adequate ring size was measured with the sizing tool and the magnetic ring was wrapped around the lower end of the lower esophageal sphincter.The msa device (linx device) was sized without foreign bodies using the designated tool while avoiding tension or compression of the esophagus and was closed until it popped off.The sizing tool was wiggled to prevent squeezing the esophagus.The median operating room time was 30 min.The surgical approach was laparoscopic in all patients.No perioperative complications were seen.The median msa-device size implanted was 15.81% of patients received additional crural closure.The median hospital stay was 1 day.None of the patients showed a complete contrast stop at the gastroesophageal junction in the first postoperative contrast swallows performed.Reported complications include residual regurgitations, residual heartburn, dysphagia, dysphagia with dyspepsia, abdominal trauma and epigastric discomfort, spastic retrosternal pain during swallowing, occurrence of a paraesophageal hiatal hernia.In conclusion, dysphagia requiring endoscopic or surgical intervention was rare after msa in a large case series.Linx devices with a size <13 were shown to be an independent risk factor for developing postoperative dysphagia.

Manufacturer Narrative

(b)(4).Date sent: 6/21/2023.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 17174999
• MDR Text Key: 317631580
• Report Number: 3008766073-2023-00110
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention